Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Decitabine Combined With Oxaliplatin in Patients With Advanced Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04049344
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Brief Summary:
The investigators reported previously that epigenetic activation of organic cation transporter (OCT2) by decitabine sensitizes RCC cells to oxaliplatin both in vitro and in xenografts. The objective of this phase II clinical trial is to investigate the efficacy and safety of sequential combination therapy with decitabine and oxaliplatin in patients with relapsed/metastatic renal cell carcinoma who progressed on standard of care.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Decitabine; Oxaliplatin Phase 2

Detailed Description:
CHUCAS-025 (Cancer Hospital, University of Chinese Academy of Sciences) is a phase II trial conducted at 3 investigative centres in the Zhejiang Province, China. Eligible patients are 18 to 75 years old with relapsed/metastatic renal cell carcinoma progressed on standard of care. Patients receive Decitabine 10 mg/day for 5 consecutive days (d1-5) plus Oxaliplatin 75mg/m2 2-week-cycle (d6, d20) within 4 weeks. One cycle is defined as 4 weeks of treatment and total of 6 cycles are designed for patients. Patients who experienced unacceptable toxicities or clinical or documented progressive disease are discontinued from the study. The duration of any objective response is measured from the date the initial response is observed to the date that disease progression is observed. Patients receiving 2 cycles of treatment are considered evaluable for response using Response Evaluation Criteria in Solid Tumors (RECIST). Disease assessment by the investigator include response assessment and diagnostic imaging and measuring of target lesions. All patients receive computed tomography and/or magnetic resonance imaging scans for assessing disease status. All patients were followed up until death from any cause.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Open-Label Single-Arm Study of Decitabine Combined With Oxaliplatin in Patients With Relapsed/Metastatic Renal Cell Carcinoma
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination of decitabine with oxaliplatin treatment
Patients receive Decitabine 10 mg/day for 5 consecutive days (d1-5) plus Oxaliplatin 75mg/m2 2-week-cycle (d6, d20) within 4 weeks. One cycle is defined as 4 weeks of treatment and total of 6 cycles are designed for patients.
Drug: Decitabine; Oxaliplatin
Patients receive Decitabine 10 mg/day for 5 consecutive days (d1-5) plus Oxaliplatin 75mg/m2 2-week-cycle (d6, d20) within 4 weeks. One cycle is defined as 4 weeks of treatment and total of 6 cycles are designed for patients.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Six months after randomization ]
    Progression free survival is defined as the time from randomization to first documented RECIST-defined tumor progression or death from any cause. Disease assessments are performed with the use of computed tomography or magnetic resonance imaging at baseline, every 8 weeks for the first year, and then every 12 weeks until disease progression or discontinuation of treatment. Imaging data were evaluated by the investigator to assess tumor response (according to RECIST version).


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Two years ]
    Overall survival is defined as the time from randomization to the date of death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Age: 18 ~75 years old.
  2. Patients who are diagnosed pathologically with relapsed/metastatic renal cell carcinoma have a disease progression on standard of care.
  3. Performance status: Eastern Cooperative Oncology Group performance status ≦2.
  4. Life expectancy more than 3 months.
  5. Patients have adequate organ function, accord with following criteria: A. blood routine: Hemoglobin≥90g/L, absolute neutrophil count≥1.5×109/L, platelet count ≥ 80×109/L; B. Biochemical tests: total bilirubin is less than 1.5 times upper limit of normal, alanine aminotransferase and aspartate aminotransferase are less than 2.5 times upper limit of normal; C. creatinine less than 1.25 times upper limit of normal.
  6. Patients agree to use adequate contraception in the period of trial and need negative pregnancy test in childbearing potential women.
  7. Patients agree to receive treatment with epigenetic drugs.
  8. Participant sign an institutional review board—approved, protocol-specific informed consent form in accordance with institutional guidelines.

Exclude criteria:

  1. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
  2. Organs failure.
  3. ECOG >2.
  4. Serious/active infection.
  5. Autoimmune disorders or immunodeficiency diseases.
  6. Patients with allergic constitution, or other disease need take drugs of immunosuppressant or corticosteroids.
  7. Uncontrolled hypertension.
  8. Myocardial ischemia (more than grade II ) or myocardial infarction or uncontrolled arrhythmia.
  9. Cardiac insufficiency of grade III to IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) <50%.
  10. Coagulation disorders, tendency of haemorrhage, undergoing thrombolytic or anticoagulant therapy.
  11. Unhealed wounds, or fractures.
  12. With a history of psychotropic drug abuse or mental disorders.
  13. Prior systemic therapies with any antitumor agents within 4 weeks.
  14. With other uncurable cancers simultaneously.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049344


Contacts
Layout table for location contacts
Contact: Wang Hua, Ph.D.; M.D. +86-571-8812-8031 ext 8031 wanghua@zjcc.org.cn
Contact: He Yedie, M.D. +86-571-8812-8031 ext 8031 525507831@qq.com

Locations
Layout table for location information
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Wang Hua, Ph.D.;M.D.    +86-571-8812-8031 ext 8031    wanghua@zjcc.org.cn   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Layout table for investigator information
Study Chair: Wang Hua, Ph.D.; M.D. Zhejiang Cancer Hospital

Layout table for additonal information
Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT04049344     History of Changes
Other Study ID Numbers: CHUCAS-025
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhejiang Cancer Hospital:
renal cell carcinoma
chemotherapy
decitabine
oxaliplatin
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Oxaliplatin
Decitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors